Manager, Safety Scientist
Skills
About the role
This is a pharmacovigilance role at BeiGene (BeOne), supporting assigned compounds alongside Product Safety Leads on signal detection, safety risk assessment and regulatory reporting. It suits a scientist or clinical professional with pharmacovigilance experience who is comfortable working across clinical trial support, regulatory inquiries and periodic safety reporting, working remotely in the US.
What you’ll do
- Support identification, analysis and evaluation of safety data for signal detection
- Perform signal detection and assessment with required documentation
- Collaborate with Product Safety Leads, scientists and pharmacoepidemiologists on safety evaluations
- Support preparation of safety data presentations for governance committees
- Review safety sections of protocols, IBs, ICFs, CSRs and other study documents
- Support authoring of periodic reports including DSURs, PADERs and PBRERs
- Respond to health authority and IRB/EC safety inquiries
What they’re looking for
- PharmD, RN or PhD/MS in a medical or biological science field
- 2+ years as a Safety (Pharmacovigilance) Scientist
- Pharmaceutical product development experience
- Experience with global pharmacovigilance regulatory requirements
- Knowledge of a safety database such as Argus
- Intermediate knowledge of MedDRA and signal management systems
Nice to have
- Familiarity with data mining tools such as Spotfire and PowerBI
What’s on offer
- Salary range $127,800-$167,800 annually
- Annual bonus plan eligibility
- Employee Stock Purchase Plan and discretionary equity awards
- Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off and Wellness benefits
Questions about this role
Is this role remote?
Yes, it's listed as Remote (US).
How much does it pay?
The stated salary range is $127,800 to $167,800 annually, plus bonus eligibility.
How many years of experience do I need?
At least 2 years of experience as a Safety (Pharmacovigilance) Scientist.
How much travel is required?
Less than 10% travel.
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